MAUDE Adverse Event Report: AGILENT TECHNOLOGIES SINGAPORE (INTL.) PTE LTD. AUTOSTAINER LINK 48; AUTOMATED SLIDE STAINER

Model Number	AS480
Medical Device Problem Codes	Fire (1245); Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The united states customer informed agilent application specialist that "a piece of equipment caught fire." following up with the customer, it was noted the customer smelled fire, but did not see it.The sprinkler system activated, and emergency services responded to the scene confirming the sprinkler system has extinguished the fire.Agilent field service engineer (fse), provided pictures that indicate multiple instruments, and laboratory equipment, were damaged by the fire, water, and smoke.Following the fire marshal's investigation a report, nfirs-2, was provided at agilent's request.The report indicates that while the root cause of ignition, and factors contributing to ignition, are unknown; the workstation computer monitor, attached to the autostainer instrument, was determined to be "involved in ignition." it was confirmed there are no injuries reported as a result of the fire.
Additional Manufacturer Narrative
This report does not constitute an admission, or a conclusion, by agilent, or its employees, that the device, agilent, or its employees caused or contributed to the event described in the report.Agilent will submit a supplemental report should additional relevant information become available.

• Brand Name: AUTOSTAINER LINK 48
• Common Device Name: AUTOMATED SLIDE STAINER
• Manufacturer (Section D): AGILENT TECHNOLOGIES SINGAPORE (INTL.) PTE LTD.; no.1 yishun avenue 7; singapore north east, sgp 76892 3; SN 768923
• Manufacturer Contact: angela bandy ; 1834 state highway 71 west; cedar creek, TX 78612 ; 3026338121
• MDR Report Key: 21473148
• Report Number: 3003423869-2025-00016
• Device Sequence Number: 8659037
• Product Code: KPA
• UDI-Device Identifier: 05700572035497
• UDI-Public: (01)05700572035497(11)190205
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 02/26/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: AS480
• Device Catalogue Number: AS48030
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2025
• Initial Report FDA Received Date: 02/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/05/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown